Some standard content:
National Standard of the People's Republic of China
Hygienic standard of disinfection for single use medical products
Hygienic standard of disinfection for single use medical productsGB15980--1995
This standard is formulated in accordance with the "Law of the People's Republic of China on the Prevention and Control of Infectious Diseases" and the "Implementation Methods of the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases". 1 Subject content and scope of application
This standard specifies the hygienic standards before and after sterilization and disinfection of disposable medical products. This standard puts forward quality control requirements for the production process and the hands of production workers in the production, assembly, and packaging workshops of disposable medical products (including sterilized and disinfected disposable medical products).
This standard is applicable to all types of disposable medical product manufacturers, and also to sterilization and disinfection service units. 2 Reference standards
GB7918.2 Standard inspection method for cosmetic microorganisms GB8368 Disposable infusion sets
GB8369 Disposable blood transfusion sets
GBJ4883 Hospital sewage discharge standard (trial) Pharmacopoeia of the People's Republic of China (1990 edition) 3 Terminology
3.1 Sterilization: Kill all microorganisms on the transmission medium by physical or chemical methods to make it sterile. 3.2 Disinfection: Kill or remove pathogenic microorganisms on the transmission medium by physical or chemical methods to make it harmless. 3.3 Sterilized disposable medical supplies: Disposable medical supplies that enter human tissues, pass the sterility, no thermal sequence, no hemolytic reaction and no abnormal toxicity tests, and must be sterilized before leaving the factory and can be used directly. 3.4 Disinfected disposable medical supplies: Disposable medical supplies that come into contact with skin and mucous membranes, pass the no toxicity test, and must be disinfected before leaving the factory and can be used directly.
4 Sterilization and disinfection standards
4.1 Disposable medical products must be sterilized and disinfected with ethylene oxide or ionizing radiation or other methods approved by the Ministry of Health. The sterilization and disinfection equipment used must have a product certificate and a health license. 4.2 When disposable medical products are sterilized or disinfected with ethylene oxide before leaving the factory, the residual amount of ethylene oxide shall not exceed 10μg/g4.3 Microbiological indicators for sterilization and disinfection:
4.3.1 Initial contamination bacteria count of the product: sterilized product pipeline lumen ≤10cfu/piece, external ≤100cfu/piece; non-pipeline ≤100cfu/piece; digital materials ≤100cfu/g; disinfected products ≤1000cfu/piece or weight (g). 4.3.2 No pathogenic bacteria shall be detected in sterilized and disinfected products. 4.3.3 The total number of bacteria in the air of production, assembly and packaging workshops, sterilization and disinfection products are ≤500 and 2000 cfu/m respectively; the total number of bacteria on the surface of objects is ≤10 and 20 cfu/cm respectively.
Approved by the State Administration of Technical Supervision on December 15, 1995 and implemented on July 1, 1996
GB 15980-1995
4.3.4 The total number of bacteria on the hands of production workers is ≤300 cfu/each hand. 4.4 Evaluation standards for sterilization and disinfection effects:
4.4.1 Evaluation standards for sterilization effects:
4.4.1.1 Ethylene oxide sterilization: Using Bacillus subtilis var. niger spores (ATCC9372) as indicator bacteria, the inactivation index reaches 10%. 4.4.1.2 Sterilization by ionizing radiation: Using Bacillus pumilus spores E601 (A1CC27142) as the indicator bacteria, the inactivation index reaches 10°4.4.1.3 Sterilization by other methods: The inactivation index of the indicator bacteria used reaches 10%. 4.4.2 Evaluation criteria for disinfection effect:
4.4.2.1 Disinfection by ethylene oxide: Using Bacillus subtilis var. niger spores (ATCC9372) as the indicator bacteria, the inactivation index reaches 10°. 4.4.2.2 Disinfection by ionizing radiation: Using Bacillus pumilus E601 (ATCC27142) as the indicator bacteria, the inactivation index reaches 10.4.4.2.3 Disinfection by other methods: The inactivation index of the indicator bacteria used reaches 103.4.4.2.4 The abnormal toxicity, pyrogen and hemolytic reaction tests of the products shall be carried out in accordance with the provisions of GB8368 and 8369. 4.5 Sterilization and disinfection quality control requirements:
4.5.1 Work systems, sterilization or disinfection procedures and technical parameters should be formulated according to the business requirements of the unit. Each operation, inspection procedures and results must be recorded and filed for future reference. 4.5.2 Both the production enterprise and the sterilization and disinfection service unit must set up a quality control room. Sterilization and disinfection must be tested with biological indicators. If unqualified products are found, they must be sterilized or disinfected again until the sterilization and disinfection effect evaluation standards in 4.4 are met. 5 Production hygiene requirements
5.1 Factory hygiene requirements
5.1.1 The factory area should be located more than 500m away from traffic arterial roads, docks, cargo yards and other areas with serious air and water pollution. The surrounding environment should be clean and tidy, and green and dust-proof. The area around the production area should be free of stagnant water, weeds, garbage, and mosquitoes, flies and pests. 5.1.2 The layout of the area is reasonable, the production area is separated from the administrative office area, and the production area should be placed on the upwind side of the main wind direction. 5.1.3 The water quality of flushing water must comply with the injection water standard of the Pharmacopoeia of the People's Republic of China (1990 edition). 5.1.4 Sewage discharge must comply with GBJ4883. 5.2 Hygiene requirements for production workshops
5.2.1 The layout of the production workshop must comply with the production process. The production, assembly, packaging, and transportation of parts and components must not be reversed or crossed. There should be strict regulations for the transportation of raw materials and the transportation of products. Disinfected or sterilized items must be placed and transported separately from non-disinfected or non-sterilized items. 5.2.2 Indoor decoration should use materials that are easy to clean, disinfection-resistant, and have no particle shedding. The surfaces of the floor, walls, ceilings, etc. should be smooth and flat, without cracks or dust accumulation. And install enough low-ozone ultraviolet lamps (30W/10m2) for air disinfection. 5.2.3 Before entering the assembly, cutting, packaging and other workshops, you must change into clean shoes, hats, work clothes and wear masks in the buffer room, and wash and disinfect your hands. The buffer room should be divided into contaminated areas and clean areas, and have obvious signs. There should be an indoor flush toilet. 5.2.4 The sterilization product production workshop (control area) must meet the 100,000-level purification standard and be equipped with an air conditioning purification system. There should also be air showers, showers and disinfection facilities. The sterilization product production workshop requires clean conditions and ventilation and dust prevention equipment. There should be equipment to prevent flies, mosquitoes, cockroaches, rats and foreign objects from mixing in.
5.2.5 The products produced should be packaged in time and the transportation vehicles should be dedicated. The packaged products should be stored in a clean room with a relative humidity not exceeding 80% and no corrosive gases and good ventilation. 5.2.6 The concentration or amount of toxic and harmful substances produced during the production process should meet the relevant national standards. 5.3 Hygiene requirements for production personnel
5.3.1 Personnel engaged in product production and disinfection and sterilization must undergo health examinations before taking up their posts and every year. Persons with active pulmonary tuberculosis, viral hepatitis, epilepsy, typhoid fever or chronic carriers, gonorrhea, and suppurative or exudative skin diseases are not allowed to engage in this work. 5.3.2 Production personnel must be trained in health knowledge (including production hygiene, personal hygiene), relevant health standards, technical specifications, and sterilization and disinfection technology. They can only engage in this work after they meet the requirements. 250
6 Supervision and testing management
GB15980—1995
6.1 Production enterprises must have testing instruments and measuring instruments to ensure product quality, and set up a quality control room. 6.2 Self-testing requirements for production enterprises:
6.2.1 The indoor temperature and humidity of the production workshop (control area) shall be measured once every shift. The room temperature standard is 18~28C and the relative humidity is 50%~65%. The wind speed is measured at the indoor air inlet once a month, and the standard is ≥0.25m/s. The air pressure is measured indoors and outdoors once a month, and the indoor and outdoor pressure difference is ≥4.9Pa. Dust particles are measured once a quarter in the passage, buffer room and key operation points, 1m above the ground and every 2m apart by the light scattering particle method, and the number of particles ≥0.5μm is ≤3500/L. If it is difficult for the enterprise to conduct self-testing, it can be entrusted to the health and epidemic prevention station in the jurisdiction.
2 At the key operation points of the production workshop (control area), the total number of bacteria in the air, on the surface of objects and on the hands of production workers is tested once a week. 6.2.2
6.2.3 For each batch of products, 10 samples are randomly selected for initial contamination bacteria count and sterility test after sterilization or bacteria count test after disinfection.
6.2.4 All the above items are recorded and archived for future reference. 7 Product packaging marks
7.1 Each set of products shall be sealed in plastic bags, and small packages shall have the following marks: a.
Manufacturer name, address and trademark;
Product name and model;
Health license number;
Instructions for use;
Sterilization method and validity period;
Date of production.
7.2 The medium packaging is sealed with a plastic bag and must have the following markings: a.
Manufacturer name and trademark;
Product model and quantity;
Date of production;
Factory batch number;
Instructions for use.
7.3 The large packaging box must have the following markings:
Product name, model and quantity;
Manufacturer name and address;
Health license number;
Product factory batch number and sterilization date;
Sterilization certificate and validity period.
8Testing methods
See Appendix A to G.
A1 Determine the total number of bacteria in the air under dynamic conditions. GB15980--1995
Appendix A
Test method for total number of bacteria in the air
(Supplement)
A2 Use the plate exposure method: for workshops with an area of more than 30m2, take samples at five points: east, west, south, north (1m away from the wall), and center; for workshops with an area of less than 30m2, take samples at three points: inside, center, and outside of a diagonal line, all at a height of 1.5m. Place ordinary nutrient agar plates (9cm diameter) according to the above sampling points and heights, close the cover immediately after exposure for 15 minutes, observe the results after incubation in a 37℃ incubator for 24 hours, and calculate the average number of bacteria at 5 or 3 sampling points. The calculation formula is shown in formula (A1):
Bacteria count/m2=50000N
Where: A—plate area, cm2;
TPlate exposure time, min;
N—average colony count.
Appendix B
Detection method for total bacteria count on object surfaces and production personnel's hands (supplement)
B1 Sampling method
Place a sterilized standard plate with an inner diameter of 5cm×5cm on the surface of the object to be inspected. According to the size of the surface area of the object, take 1 to 4 parallel samples, use a cotton swab soaked in sterile saline to smear the inside of the standard plate 10 times (round trip counts as 1 time), and put the cotton swab into a sampling tube containing 10mL sterile saline. Sampling of production staff's hands: the inspected person puts five fingers together, and smears the cotton swab soaked in sterile saline on the curved surface of the right finger from the fingertip, nail groove to the base of the finger 10 times back and forth, and then puts the cotton swab into a test tube of 10mL sterile saline. B2 Test method and result calculation
Shake each sampling tube 80 times, mix well, dilute 10 times in descending order, take 1mL for each dilution (take 3 dilutions) and put it in sterile flat III (pour 2 plates for each dilution), use ordinary agar medium for pouring culture, and culture in a 37℃ incubator for 24 hours, observe the results, take the plate with 30 to 300 colonies for calculation, and calculate the average colony count. Bacteria count/cm2=average bacteria count×dilution factor
Sampling area (cm2)
Bacteria count/each hand=average bacteria count×dilution factor...
Appendix C
Initial contamination bacteria count detection
(Supplement)
C1 Sampling method
..(B1)
C1.1 For medical supplies that can be sampled by destructive methods, such as infusion (blood) sets, syringes, injection needles, dialyzers and various catheters, the provisions of the Pharmacopoeia of the People's Republic of China (1990 edition) shall be followed. C1.2 For special medical supplies that cannot be sampled by destructive methods, cotton swabs soaked in saline can be used for smearing and sampling. If the sampled surface is <100cm2, the entire surface can be sampled; if the sampled surface is ≥100cm2, 100cm2 can be sampled. C1.3 For dressings, 10g can be taken by aseptic procedures, placed in 100mL sterile saline, and sampled after sufficient shaking. 252
GB15980--1995
C1.4 Sampling quantity: 10 samples are randomly selected from each batch of various products. C2 Test method and result calculation
Take 5 parallel samples for each sample, and the test method shall refer to the provisions of GB7918.2. The calculation formula is: average bacterial count × dilution factor
Bacterial count/each item (or g)-
Item or weight (g)
Appendix D
Stemless inspection method
(Supplement)
D1 Sterility inspection method
According to the provisions of "Sterility Inspection Method" of the Pharmacopoeia of the People's Republic of China (1990 Edition). D2 Sampling method
According to Chapter C1.
Appendix E
Ionizing radiation sterilization or mildew removal test method
(Supplement)
E1 Regular testing can use a dose meter. ·(C2)
E2 Each batch of products must be tested for sterilization or disinfection effect. Taking Bacillus brevis spores E601 (ATCC27142) as the indicator bacteria, each piece of bacteria is 5×105106 (when sterilizing) or 10 when disinfecting), the dose D1 value required to kill 90% of microorganisms is 1.7kGy. At the minimum dose, at least 10 pieces of biological indicators are placed each time.
E3 Evaluation criteria for sterilization or disinfection effect: After sterilization or disinfection, the recovered bacterial pieces are continuously cultured (37C) for 7 days without sterile growth, and the sterilization or disinfection can be reported as qualified. At the same time, positive controls are set up.
Appendix F
Testing the sterilization or disinfection effect of ethylene oxide
(Supplement)
F1 Each batch of products must be tested for disinfection or sterilization effect. Use Bacillus subtilis var. niger spores (ATCC9372) as indicator bacteria, cloth pieces or thick filter paper pieces (0.5×1.0cm2) as carriers, and the number of bacteria per piece is 5×105～105 (for sterilization) or 10* (for disinfection). When the ethylene oxide agent is 600±30mg/L, 54℃, and relative humidity is 60%, the time D required to kill 90% of microorganisms is 2.6～5.8min. At the most difficult place to kill. The upper layer is placed at three points in the middle and outside of the diagonal line, and two points in the middle layer. Two biological indicators are placed in parallel at each point and placed in the outer packaging of each point. F2 Sterilization or disinfection effect evaluation standard: after sterilization or disinfection, the bacterial slices are recovered and continuously cultured (37℃) for 7 days without aseptic growth, and the sterilization or disinfection can be reported as qualified. At the same time, a positive control is set.
Appendix G
Test method for ethylene oxide residue in products
(Supplement)
G1 Test purpose
To determine the time for product activation after disinfection. When the raw materials and disinfection process of the product are changed, a sub-test should be conducted. 253
G2 Sample collection
GB15980—1995bZxz.net
After ethylene oxide sterilization, a certain amount of small package samples are randomly selected from three large packages of the same disinfection batch number. The sampling volume should be sufficient for at least two tests.
The residual amount is measured 24 hours after ethylene oxide sterilization and every few days thereafter until the residual amount drops below the standard value specified in Article 4.2.
G3 instrument operating conditions
Instrument: gas chromatograph, hydrogen flame detector. Operating conditions:
Column: Chromosorb W.HP, 80 mesh; glass column length 2m, diameter 3mm. Column temperature: 120℃.
Detector: 150℃C.
Gasification: 150℃.
Carrier gas volume: nitrogen: 35mL/min;
Hydrogen: 35mL/min,
Air: 350mL/min.
Pressure before column: 108kPa.
G4 Operation steps
G4.1 Standard preparation
Use a 100mL glass needle to extract ethylene oxide standard gas from a small pure ethylene oxide cylinder (repeat the emptying twice to remove the original air), plug the rubber head, use a 10ml syringe to extract 10mL of pure ethylene oxide standard gas from the above 100mL syringe, and dilute it to 100mL with nitrogen (this can be done by injecting 10ml of standard gas into a needle with a rubber stopper that already has 90mL of nitrogen). Use the same method to dilute it step by step 2 to 3 times as needed (dilute 1000~~10000 times) to make three concentrations of standard gas. Calculate the ethylene oxide concentration in the final standard gas according to the purity of ethylene oxide in the small ethylene oxide cylinder, the dilution multiple and the room temperature. The calculation formula is shown in G1:
40×106
X273+t
22.4×103×K
Where: c—standard gas concentration, ug/mL; K——dilution factor
t—room temperature.
G4.2 Sample treatment
Take at least 2 minimum packaged products, cut them into pieces, accurately weigh 2g at random, put them into the extraction container, add 5mL of chloroform or acetone, shake well, and leave for 4h or oscillate for 0.5h for standby use. G4.3 Analysis
After the instrument is stable, under the same conditions, inject 0.5μL, 2uL of each sample to be analyzed is injected. Qualitative analysis is performed based on retention time, and quantitative calculation is performed based on peak area (or peak height). G4.4 Calculation
Use the number of grams (μg) of ethylene oxide standard gas injected to the peak area (or peak height) to make an ethylene oxide working curve. The amount of ethylene oxide A (μg) is calculated on the working curve based on the peak area (or peak height) corresponding to ethylene oxide in the sample, and the residual amount of ethylene oxide in the product is calculated using formula (G2). A
mxVin
Where: X——Residual amount of ethylene oxide in the product μg/g; A—Amount of ethylene oxide found from the working curve, μg254
m-Amount of sample taken, g;
V*Volume of extract, mL;
Vinjection volume, mL.
Additional Notes:
This standard was proposed by the Ministry of Health of the People's Republic of China. This standard was drafted by the Liaoning Provincial Health and Epidemic Prevention Station. The main drafters of this standard were Zhang Huixian, Cui Sen, Gu Jingyu, and Zhai Tingbao. This standard is interpreted by the Ministry of Health's technical unit, the Ministry of Health's Communicable Disease Supervision and Management Office. 25.
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